Study of Bendamustine, Gemcitabine and Vinorelbine Regimen in Relapsed/Refractory Classical Hodgkin Lymphoma (BEGEV)

Study of Bendamustine, Gemcitabine and Vinorelbine (BEGEV) Chemotherapeutic Regimen in Relapsed/Refractory Classical Hodgkin Lymphoma

The goal of this phase III clinical trial was to make a direct head to head comparison between the chemotherapeutics; Bendamustine, Gemcitabine and Vinorelbine (BEGEV) and the the Gemcitabine, Dexamethasone and Cisplatin (GDP) regimens in the settings of relapsed and refractory classical Hodgkin lymphoma.

Patients were allocated and randomly assigned to either arm. Cycles were received as out-patient setting, every 21 days. Patients were assessed by clinical and routine labs, before receiving the cycle. Efficacy was assessed by performing Positron Emission Tomography (PET-CT) after three cycles. Toxicity was reported according to the National Cancer Institute Common Terminology Criteria of AEs v4.0 and was dealt with accordingly. Patients attained at least partial response (PR) was sent for high dose chemotherapy followed by autologous stem cell rescue(HDC/ASCR). Patients were followed up for a total of 1 year

Study Overview

• Status: Completed
• Conditions: Classical Hodgkin Lymphoma Relapsed
• Intervention / Treatment: Combination product: BEGEV (Bendamustine, Gemcitabine,Vinorelbine); Combination product: GDP(Gemcitabine, Dexamethasone and Cisplatin)

Detailed Description

Patients with primary refractory and relapsed classical Hodgkin lymphoma attended the medical oncology department at the National Cancer Institute, Cairo University, Egypt during the period from April, 2024 to October, 2024 were randomly assigned in the 2 treatment groups using online random number generator.

Exclusion criteria include age less than 18 year, Eastern Cooperative Oncology Group(ECOG) performance status less than 2, pregnancy, second cancers chronic kidney disease, end stage renal disease, liver cell failure, HIV, HCV, HBV, and autoimmune diseases.

The basic, epidemiological, clinical, laboratory, pathological, and radiological data, and complete staging was recorded at the baseline.

The BEGEV regimen was administered as follows: gemcitabine 800 mg/m2 and prednisolone 100 mg per day on days 1 and 4, vinorelbine 20 mg/m2 on day 1, and bendamustine 90 mg/m2 on days 2 and 3.

The GDP regimen was administered as follows: Gemcitabine 1000 mg/m2 days 1 and 8, dexamethasone 20 mg/m2 days 1-4 and days 11-14 and cisplatin 25 mg/m2 days 1-3.

Cycles were repeated every 21 days for a total of 4 cycles, guided by the clinical situation.

Side effects were reported according to National Cancer Institute Common Terminology Criteria of AEs v4.0 and was dealt with accordingly.

Interim evaluation was done after 3 cycles and response was reported according to the International Workshop for Response Criteria for non-Hodgkin lymphomas.

Patients who attained at least partial response were sent for autologous stem cell transplantation and the same evaluation was repeated post-transplant.

Patients was followed every 3 months for a total of 1 year and relapse, mortality, progression free survival, disease free survival, and overall survival, were recorded.

Sample size calculation:

A study conducted by Stefoni et al. (2023) assessed the effectiveness of BEGEV regimen and reported that the overall response rate was 76.7%, another study by Rybka et al. (2015) assessed the effectiveness of GDP regimen and reported that the overall response rate was 31% in Hodgkin lymphoma patients. A total sample size of 44 (22 in each group) was needed for this study with alpha 5% and power 80%. Sample size calculation was done using MedCalc program version 18.2.1.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • From Elkhart
    • Cairo, From Elkhart, Egypt, 11796
      • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Primary refractory classical Hodgkin lymphoma Relapsed classical Hodgkin lymphoma Age 18 years old or more Both genders Eligible to receive the chemotherapeutic protocol.

Exclusion Criteria:

Eastern Cooperative Oncology Group(ECOG) performance status less than 2. Pregnancy. Second cancers. Chronic kidney disease End stage renal disease Liver cell failure HIV HCV HBV Autoimmune diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BEGEV arm (Bendamustine, Gemcitabine and Vinorelbine); Received the BEGEV protocol	Combination product: BEGEV (Bendamustine, Gemcitabine,Vinorelbine); Gemcitabine 800 mg/m2 and prednisolone 100 mg per day on days 1 and 4. Vinorelbine 20 mg/m2 on day 1. Bendamustine 90 mg/m2 on days 2 and 3.
Active Comparator: GDP arm (Gemcitabine,Dexamethasone,Cisplatin); Received the GDP protocol	Combination product: GDP(Gemcitabine, Dexamethasone and Cisplatin); Gemcitabine 1000 mg/m2 days 1 and 8. Dexamethasone 20 mg/m2 days 1-4 and days 11-14 Cisplatin 25 mg/m2 days 1-3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate	According to the International Workshop for Response Criteria for non-Hodgkin lymphomas. The response is classified as either complete response (CR), partial response (PR), stable disease(SD) or progressive disease (PD). The sum of CR and PR is labelled as overall response rate.	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	Calculated from the start of the intervention to the first disease progression or death	20 months
Disease free survival	Calculated from the first documented response to the first disease relapse or death that is related to the disease or the acute toxicity of the therapy	20 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 1-Ansell SM. Hodgkin lymphoma: 2023 update on diagnosis, risk-stratification, and management. Am J Hematol. 2022; 97(11): 1478-1488. doi:10.1002/ajh.26717 https://onlinelibrary.wiley.com/doi/10.1002/ajh.26717 2-Ansell S.M., Radford J., Connors J.M., Długosz-Danecka M., Kim W.-S., Gallamini A., Ramchandren R., Friedberg J.W., Advani R., Hutchings M., et al. Overall Survival with Brentuximab Vedotin in Stage III or IV Hodgkin's Lymphoma. N. Engl. J. Med. 2022; 387:310-320. doi:10.1056/NEJMoa2206125.https://pubmed.ncbi.nlm.nih.gov/35830649/ 3-Arai S, Fanale M, DeVos S, Engert A et al. Defining a Hodgkin lymphoma population for novel therapeutics after relapse from autologous hematopoietic cell transplant. Leuk Lymphoma.2013; 54:2531-2533. https://doi.org/10.3109/10428194.2013.798868 4-Santoro A, Magagnoli M, Spina M et al. Ifosfamide, gemcitabine, and vinorelbine: a new induction regimen for refractory and relapsed Hodgkin's lymphoma. Haematologica.2007; 92:35-41. https:// doi.org/10.3324/haematol.10661 https://pubmed.ncbi.nlm.nih.gov/17229633/ 5- Santoro A, Mazza R, Pulsoni A et al. Bendamustine in combination with gemcitabine and vinorelbine is an efective regimen as induction chemotherapy before autologous stem-cell transplantation for relapsed or refractory Hodgkin lymphoma: fnal results of a multicenter phase II study. J Clin Oncol.2016; 34:3293-3299. https://pubmed.ncbi.nlm.nih.gov/27382096/ 6- Stefoni V, Argnani L, Carella M, Casadei B, Morigi A, Lolli G, Broccoli A, Pellegrini C, Nanni L, Coppola PE, Zinzani PL. BEGEV salvage regimen in relapsed/refractory classical Hodgkin lymphoma: a real-life experience. J Cancer Res Clin Oncol. 2023 Mar;149(3):1043-1047. doi: 10.1007/s00432-022-03955-w. Epub 2022 Mar 3. PMID: 35239000; PMCID: PMC9984336. https://pubmed.ncbi.nlm.nih.gov/35239000/ 7- Rybka J, Jurczak W, Giza A, Paszkiewicz-Kozik E, Kumiega B, Drozd-Sokołowska J, Butrym A, Kuliczkowski K, Wróbel T. Gemcitabine-Based Treatment in Poor-Prognosis Patient

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: BEGEV; GDP; Refractory classical Hodgkin Lymphoma; Relapsed classical Hodgkin Lymphoma
• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Acids, Acyclic; Carboxylic Acids; Alkaloids; Polycyclic Compounds; Indoles; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Pregnadienetriols; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indolizidines; Indolizines; Platinum Compounds; Butyrates; Bendamustine Hydrochloride; Vinorelbine; Gemcitabine; Dexamethasone; Cisplatin
• Other Study ID Numbers: MO2404-205-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No